Ex Parte Sharareh et al

Patent Trial and Appeal Board

Jul 31, 2018

11414009 (P.T.A.B. Jul. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/414,009 04/27/2006 Shiva S. Sharareh
24981 7590 08/02/2018
Lawrence Livermore National Security, LLC
LA WREN CE LIVERMORE NATIONAL LABORATORY
PO BOX 808, L-703
LIVERMORE, CA 94551-0808
UNITED ST A TES OF AMERICA
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
IL-11684 2549
EXAMINER
EISEMAN, LYNSEY C
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/02/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
llnl-docket@llnl.gov
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHIV AS. SHARAREH and STAVROS DEMOS
Appeal2017-002351
Application 11/414,009 1
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and DAVID COTTA,
Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
spectroscopic method for real-time examination of biological tissue. The
Examiner rejected the claims on appeal under 35 U.S.C. § 112 as indefinite
for failing to particularly point out and distinctly claim the subject matter
which the inventor regards as the invention, under 35 U.S.C. § 102(b) as
anticipated, and under 35 U.S.C. § 103(a) as obvious.
We affirm.
1 According to Appellants, the real parties in interest are Lawrence
Livermore National Security, LLC and the United States of America as
represented by the United States Department of Energy. App. Br. 2.
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Application 11/414,009
STATEMENT OF THE CASE
The Specification discloses that "[t]he present invention relates to
optical interrogation configurations for investigating tissue modification in
real-time during medical procedures." Spec. ,r 3.
Claims 114--136 are on appeal. Claims 114 and 136 are illustrative
and read as follows:
114. A spectroscopic method for real-time examination of
biological tissue, comprising:
directing, through one or more first optical conduits,
interrogation radiation at a biological tissue site comprising
tissue undergoing modification, wherein said modification
produces a lesion, wherein said interrogation radiation produces
induced backscattered radiation;
collecting, into one or more second optical conduits, at
least a portion of said induced backscattered radiation;
measuring one or more elastic light scattering spectra
resulting from said induced backscattered radiation, wherein
said spectra comprises a spectral profile; and
utilizing changes in said spectral profile to determine in
real-time, while said tissue is undergoing modification, a depth
of penetration of said lesion.
136. The method of claim 114, wherein said depth is
measured from the surface of said biological tissue.
App. Br. 17, 21.
The claims stand rejected as follows: 2
2 In the Examiner's Answer, the Examiner withdrew the rejection of claim
136 under 35 U.S.C. § 112 as failing to comply with the written description
requirement because it included new matter. Ans. 7. Accordingly, the
rejection is no longer a part of this appeal.
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Claim 136 stands rejected under 35 U.S.C. § 112(b) or pre-AIA 35
U.S.C. § 112, second paragraph for failing to particularly point out and
distinctly claim the subject matter which the inventor regards as the
invention.
Claims 114--123, 125-128, and 130-136 stand rejected under 35
U.S.C. § I02(b) as anticipated by Balbierz. 3
Claim 124 stands rejected under 35 U.S.C. § I03(a) as obvious over
the combination of Balbierz and Ostrovsky. 4
Claim 129 stands rejected under 35 U.S.C. § I03(a) as obvious over
Balbierz.
INDEFINITENESS
In rejecting claim 136 as indefinite, the Examiner found the claim
confusing because it recites "said depth is measured" but "measuring has
never been previously recited in the claims, so it's unclear as to what this is
referring to." Ans. 8. However, claim 114, from which claim 136 depends,
recites "utilizing changes in said spectral profile to determine ... a depth of
penetration of said lesion." We agree with Appellants that determining a
depth is generic to measuring a depth and thus claim 13 6 is not indefinite on
the ground that a measurement is not previously recited in the claims. See,
Reply. Br. 4.
The Examiner also found claim 13 6 indefinite because the term "the
surface" lacks antecedent basis. We are not persuaded that this renders
3 Balbierz et al., US Patent Publication No. 2002/0026127 Al, published
Feb. 28, 2002 ("Balbierz").
4 Ostrovsky, US Patent No. 6,381,490 Bl, issued Apr. 30, 2002
("Ostrovsky").
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Application 11/414,009
claim 136 indefinite because, as Appellants point out, the term "surface" is
inherent in all tissue. Id. at 3. The Examiner does not dispute this point,
and, in fact, agrees that a "surface" is inherent in a depth of penetration.
Ans. 8. Accordingly, we reverse the Examiner's rejection of claim 136 as
indefinite.
ANTICIPATION
Findings of Fact
1. Balbierz discloses a "method and apparatus for performing
in vivo tissue biopsy using optical methods." Balbierz ,r 2.
2. Figure 4 of Balbierz is reproduced below.
FIG. 4
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Figure 4 "is a perspective view illustrating an embodiment of a biopsy and
treatment apparatus having an emitting member and detecting member
positionable in the resilient member." Id. ,r 13.
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Application 11/414,009
3. Figure 5 of Balbierz is reproduced below.
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Figure 5 "is a schematic view illustrating various optical tissue interactions
and properties." Id. ,r 14.
4. Balbierz discloses
Referring now to FIGS. 4 and 5, in an embodiment, two
sensing members 22m can be positioned in a lumen 72 of one
or more resilient members 18: a light emitting member 22me,
configured to emit an incident or probe beam 22ib; and a light
detecting member 22md, configured to detect returning light
22rb resulting from various optical tissue interactions
(including scatter, reflectance or absorbance) of incident beam
22ib by tissue 5 as is shown in FIG. 5.
Id. ,I 50.
5. Figure 6 of Balbierz is reproduced below.
FIG. 6
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Figure 6 "is a perspective view illustrating an embodiment [ ofJ the sensing
members fixedly positioned within the resilient member." Id. ,r 15.
6. Balbierz discloses:
In an alternative embodiment shown in FIG. 6, sensing
members 22 including emitting member 22me and detecting
member 22md 22me can be fixedly positioned within resilient
member 18 such that their distal ends are substantially flush
with the distal end 18de of resilient member 18 or can fixed in
other arrangements such as protruding slightly out of distal end
18de by several thousandths of inch or more or being recessed
by a similar amount within distal end 18de.
Id. ,I 52.
7. Balbierz discloses:
In an embodiment shown in FIG. 13, apparatus 10 and sensor
array 20a are configured to probe/scan the tissue volume 5"
simultaneously in 3 dimensions ( e.g. volumetrically sample) to
determine the border 5"b of tumor mass 5" so as to locate and
map the tumor mass 5" in 3 dimensions .... The generation of
3D map 4" allows the user to accurately position energy
delivery members 18e within tumor mass 5" while establishing
the position of and avoiding nearby critical anatomical
structures 5cs. . . In related embodiments detectors 22me can be
configured to monitor in the near infrared range to produce an
infrared/thermal image 4ir of sample volume 5sv that can
include tumor mass 5" or ablation volume 5av.
Id. ,I 74.
8. Balbierz discloses
In addition to identifying tissue types, apparatus 10 and sensor
arrays 22a can also be employed to monitor the progression of
an ablative procedure including the progression of an ablation
volume 5av resulting from the delivery of energy to target tissue
volume 5. Referring now to FIGS.14a and 14b, emitters 22a and
detectors 22md can be configured to monitor the moving
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boundary layer of cell necrosis 55 and/or thermal fronts 55t of a
developing ablation volume 5av. This can be achieved by
monitoring for the presence of metabolic chomophores 33 or
markers 9 indicative of cell necrosis or ablation described herein.
The spectral signal intensity 19s ( at one or more wave lengths 7)
for a volume of tissue between one or more emitters 22me and
detector 22md can be monitored over time. An endpoint for
ablation can be determined based on either a selectable threshold
value 19ts of signal 19s or an inflection point or change in slope
19ds (e.g. a derivative) of curve 19s or a combination of both.
Id. ,T 75.
9. Balbierz discloses: "Device 20ed can also be configured to
superimpose ablation volume image 4av onto tumor volume image 4" or
tissue site image 4' as well as superimpose visual cues 4c on the placement
(including proper and improper placement) of apparatus 10." Id. iT 78.
Analysis
Appellants argue claims 114--123, 125-128, and 130-136 together.
We designate claim 114 as representative.
Balbierz discloses a "method and apparatus for performing in vivo
tissue biopsy using optical methods." FF 1. In Balbierz' s method, radiation
is directed through optical conduits to a tissue site undergoing modification,
producing backscattered radiation. FF2-FF6. The light scattering spectra is
measured and changes in the spectral profile are used in real time to
determine a depth of penetration of ablated tissue. FF3, FF7-FF9. The
Examiner finds that Balbierz discloses all of the elements of claim 114. We
agree with the Examiner that Balbierz anticipates claim 114. We address
Appellants' arguments below.
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Appellants argue that in Balbierz, "[i]t is clear that the sensors are
inserted inside the tissue to be interrogated and therefore, the method is not
non-invasive as is the present invention and the specification of claim 114 of
the present invention." App. Br. 9. In response to the Examiner's position
that the claims do not require a non-invasive method, Appellants argue:
The noninvasive feature of the present invention is described in
the base claim of the present invention as "directing, through
one or more first optical conduits, interrogation radiation at a
biological tissue site comprising tissue undergoing
modification, wherein said modification produces a lesion,
wherein said interrogation radiation produces induced
backscattered radiation". Thus, the radiation is directed at a site
(the lesion). It is clear from the language of the claim that the
optical conduits are positioned to direct radiation at the site, and
thus, the conduits are external to the site, and therefore, external
to the lesion. Therefore, in contrast with Balbierz, claim 114
provides for non-invasive determination of the lesion depth.
Reply Br. 5---6. Appellants further argue that the claims must be read in view
of the Specification which identifies one of the benefits of "utilizing NIR
[near-infrared] as an analysis means when coupled to probes as discussed
herein" as being "non-invasively provided information from the surface as
well as below the surface of the tissue." Reply Br. 6. Appellants note that
"FIGs. 2A and 2B show a catheter inserted in a tissue cavity produced by
ablation, wherein ... [t]he catheter is not inserted into the lesion." Id. We
are not persuaded.
We agree with the Examiner that "[t]here is nothing in the claims that
requires this method to be non-invasive." Ans. 9. While claim 114 does
require "directing ... interrogation radiation" "through ... optical conduits
... at a biological tissue site," this does not preclude invasive methods. So
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long as radiation is directed through optical conduits at a biological tissue
site, it does not matter - for purposes of determining whether this claim
limitation is met - whether the instrument generating the radiation is
"invasive." The fact that the Specification discloses the benefit of "non-
invasively provided information" cannot overcome the absence of limiting
language in the claims. Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed.
Cir. 1988) ("[W]hile it is true that claims are to be interpreted in light of the
specification ... , it does not follow that limitations from the specification
may be read into the claims .... [T]he claims define the invention.").
Similarly, the disclosure of an allegedly non-invasive embodiment in the
Specification does not limit claim 114 to that embodiment in the absence of
claim language corresponding to the embodiment. 5 Bayer AG v. Biovail
Corp., 279 F.3d 1340, 1348 (Fed. Cir. 2002) ("a court may not read into a
claim a limitation from a preferred embodiment, if that limitation is not
present in the claim itself.").
Appellants argue that the radiation in Balbierz is "not directed into a
tissue that is 'comprising tissue undergoing modification' but in tissue that is
desired to undergo modification but the interrogated tissue at these locations
begins undergoing modification at different time points and not from the
beginning of the process." App. Br. 9. We are not persuaded.
Balbierz expressly discloses directing radiation at tissue undergoing
modification. See FF8 ("apparatus 10 and sensor arrays 22a can also be
5 Appellants contend that Figures 2(a) and 2(b) of the present Specification
show a non-invasive embodiment in which "the catheter is not inserted into
the lesion." Reply Br. 6. However, Figure 2(b) appears to show catheter 20'
inserted into lesion 23.
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employed to monitor the progression of an ablative procedure including the
progression of an ablation volume"). There is nothing in the language of
claim 114 that requires the radiation directed at the tissue undergoing
modification to be directed at the tissue from the beginning of the
modification process, as argued by Appellants.
Appellants argue that the sensors in Balbierz are used to "differentiate
or identify tissue at the tissue site" rather than to "obtain information about
one or more spatial dimensions of the ablation lesion." App. Br. 9-10. We
are not persuaded.
Balbierz discloses that its sensor arrays can be "employed to monitor
the progression of an ablative procedure including the progression of an
ablation volume" and that its emitters and detectors can be configured to
"monitor the moving boundary layer of cell necrosis 55 and/or thermal
fronts 55t of a developing ablation volume 5av." FF8. We agree with the
Examiner that "the 'moving boundary' is the current depth of penetration" of
the lesion being ablated and thus that Balbierz discloses determining a depth
of penetration of a lesion undergoing modification. Ans. 10. Appellants
contend that the disclosure of monitoring the moving boundary is
insufficient because "[t]here is no teaching within the reference of a way to
monitor the moving boundary layer in real time .... Simply stating and
restating that the moving boundary layer can be monitored without teaching
a method of accomplishing it is useless." Reply Br. 7. This argument is
unpersuasive because prior art cited by an examiner is presumed to be
enabling. In re Sasse, 629 F.2d 675, 681 (CCPA 1980); see also In re Antor
Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). Once a prior art
reference is found, the burden is on the Appellants to provide evidence
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rebutting the presumption. Id. Here, Appellants have not directed us to
sufficient evidence in the record to rebut the presumption that Balbierz
enabled the skilled artisan to monitor the moving boundary layer of cell
necrosis or thermal fronts of a developing ablation volume. In re Sasse, 629
F.2d at 681.
Moreover, Balbierz also discloses generating a three-dimensional map
of a tumor and superimposing the ablation volume onto this image in order
to determine the size of the ablation volume relative to the tumor. FF7, FF9.
We agree with the Examiner that it is "clear that this mapping is done in
real-time to show the surgeon the boundaries of the current ablation volume,
as compared to desired/future volume that still needs to be ablated." Ans.
11. We further agree with the Examiner that "[v]isually displaying to the
user the current depth of ablation reads on applicant's limitation of 'to
determine in real-time, while said tissue is undergoing modification, a depth
of penetration of said lesion'." Id.
Appellants point to the reference in paragraph 7 5 of Balbierz to
determining "[a]n endpoint for ablation ... based on either a selectable
threshold value 19ts of signal 19s or an inflection point or a change in slope
19ds (e.g. a derivative) of curve 19s or a combination of both," (see FF8)
and argue that Balbierz "does not teach a real-time measurement of depth
wherein the measurement is performed simultaneously with material
modification." App. Br. 13. We are not persuaded. As the Examiner
explains:
While Balbierz states that "an endpoint for ablation can be
determined", . . . when considering the entire disclosure of
Balbierz (not this single sentence, as applicant seems to be
doing), it is clear that this determination is not just occurring at
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the end point but throughout the entire progression of the
ablation volume in order to monitor the progress of the ablative
procedure.
Ans. 12. Moreover, even if depth of penetration were determined only at the
end point of ablation procedure, it would still meet the limitations of claim
114. While claim 114 does require determining "a depth of penetration" "in
real time" it does not require a continuous determination of the depth of
penetration that occurs throughout the tissue modification procedure.
Accordingly, a single real time determination of the depth of penetration -
e.g., a determination made only at the end point - would meet requirements
of claim 114.
Appellants argue that in Balbierz "the volume is always inside the
tissue and therefore, no volume defined within Balbierz will have depth as
one of the spatial dimensions." App. Br. 15. We do not read the term
"depth of penetration" so narrowly. As Appellants explain, "the definition
of depth is 'the distance from the top or surface of something to its bottom.'"
App. Br. 5. We see no reason why a lesion formed within tissue cannot have
a top and a bottom.
Accordingly, we affirm the Examiner's rejection of claim 114 as
anticipated by Balbierz. Appellants did not argue claims 115-123, 125-128,
and 130-136 separately in the Appeal Brief, arguing only that "[a]lthough
[Balbierz] uses a spectrograph, it does not teach the steps recited in claims
115-120 and 133." App. Br. 15-16. In re Lovin, 652 F.3d 1349, 1357 (Fed.
Cir. 2011) (37 C.F.R. § 41.37 requires "more substantive arguments in an
appeal brief than a mere recitation of the claim elements and a naked
assertion that the corresponding elements were not found in the prior art.").
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Appellants offer more detailed arguments for the dependent claims in their
Reply Brief; however, we find that these arguments were waived because
Appellants did not raise them in their Appeal Brief, depriving us of the
benefit of the Examiner's response. See 37 C.F.R. § 4I.41(b)(2), Ex parte
Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("[T]he reply
brief [is not] an opportunity to make arguments that could have been made
in the principal brief on appeal to rebut the Examiner's rejections, but were
not."). Accordingly, claims 115-123, 125-128, and 130-136 fall with claim
114.
Appellants argue that the Examiner's rejection of dependent claim
124 as obvious over the combination of Balbierz and Ostrovsky and of
dependent claim 129 as obvious over Balbierz should be reversed because
they depend from claim 114. App. Br. 16. We are not persuaded for the
reasons discussed above with respect to claim 114. Accordingly, we affirm
the Examiner's rejection of claims 124 and 129.
SUMMARY
In summary, for the reasons set forth herein, and those set forth in the
Examiner's Final Office Action and Answer, we affirm: the Examiner's
rejection of claims 114--123, 125-128, and 130-136 under 35 U.S.C. §
102(b) as anticipated by Balbierz; the Examiner's rejection of claim 124
under 35 U.S.C. § 103(a) as obvious over the combination ofBalbierz and
Ostrovsky; and the Examiner's rejection of claim 129 under 35 U.S.C. §
103(a) as obvious over Balbierz.
For the reasons discussed above, we reverse the Examiner's rejection
of claim 136 under 35 U.S.C. § 112(b) or pre-AIA 35 U.S.C. § 112, second
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paragraph for failing to particularly point out and distinctly claim the subject
matter which the inventor regards as the invention.
AFFIRMED
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